Safety of Levodopa-Carbidopa Intestinal Gel Treatment in Patients with Advanced Parkinson’s Disease Receiving ≥2000 mg Daily Dose of Levodopa
Table 6
AEs and ADRs that led to discontinuation.
Phase III program
Patients, n (%)
Levodopa <2000 mg/day (n = 340)
Levodopa ≥2000 mg/day (n = 72)
Overall (N = 412)
Incidence of AEs leading to discontinuation
59 (17.4)
18 (25.0)
77 (18.7)
AEs leading to discontinuation in >2 patients overall
Death
9 (2.6)
1 (1.4)
10 (2.4)
Pneumonia
4 (1.2)
1 (1.4)
5 (1.2)
Myocardial infarction
3 (0.9)
1 (1.4)
4 (1.0)
Cardiac arrest
1 (0.3)
2 (2.8)
3 (0.7)
Fall
2 (0.6)
1 (1.4)
3 (0.7)
Parkinson’s diseasea
3 (0.9)
—
3 (0.7)
GLORIA registry
Levodopa <2000 mg/day (n = 309)
Levodopa ≥2000 mg/day (n = 47)
Overall (N = 356)
Patients with ≥1 ADRb leading to discontinuation
24 (7.8)
—
24 (6.7)
ADRs leading to discontinuation in 2 patientsc overall
No ADRs met this criterion
aRefers to the reemergence of Parkinson’s disease symptoms, often due to a problem with drug delivery. bADRs were AEs deemed by the investigator to have at least a reasonable possibility of a causal relationship to the treatment drug/device. cExcluding those associated with the procedure/device. ADR: adverse drug reaction; AE: adverse event.
